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Can a blood vessel drug save kidneys in scleroderma crisis?

NCT ID NCT01241383

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called bosentan in 16 adults with scleroderma who had a serious kidney complication called scleroderma renal crisis. The goal was to see if bosentan could help protect kidney function and improve survival over 6 months to a year. The drug works by blocking a substance that narrows blood vessels, which may reduce kidney damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

16 people

The number who actually took part.

Started

Dec 2010

Finished

Jun 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men or women ≥ 18 years * Patients had to fulfil ACR and/or LEROY et MEDSGER criteria for systemic sclerosis * Patients had to fulfil criteria for renal systemic sclerosis * Written informed consent obtained Exclusion Criteria: * Scleroderma renal crisis occuring before the age of eighteen * Patients who are receiving bosentan within one month of inclusion for pulmonary arterial hypertension or digital ulcers prevention * Other treatment by selective or nonselective antagonist endothelin receptor * Left ventricle systolic dysfunction (EF \< 40 %) * Patients with systolic blood pressure \< 85mm Hg * Progressive cancer or considered cured for less than 5 years * Patients with a known hypersensitivity to bosentan or any of the excipients * Patients with HIV, HCV, HBV infection * Patients with Liver disease Child-Pugh B and C * Patients who are pregnant or breast-feeding * Women of child-bearing age who are sexually active without practising reliable methods of contraception * Patients who do not give informed consent

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scleroderma renal crisis

Contacts and locations

Locations

  • Pôle de médecine interne Centre de référence Maladies rares Groupe I Maladies systémiques et maladies auto-immunes rares en particulier Vascularites nécrosantes et les sclérodermies - Hôpital Cochin

    Paris, 75014, France